Pharma Blog Watch

A Closer Look at Galvus (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses the announcement by Novartis that it received an FDA approval letter for Galvus. "Seems that FDA remains concerned about the skin lesions Novartis observed in its one-year monkey tox study, despite the lack of similar lesions being observed in humans," he writes. "It's asked the company to conduct further clinical study or studies to investigate the finding further, specifically requesting a clinical study in patients with renal impairment."

"Despite the allure of chalking up FDA's approvable decision on Galvus to a case of the cautious pneumonia, it's impossible to understand the logic behind FDA's decision and to speculate intelligently on what Novartis will have to demonstrate to gain U.S. marketing approval for Galvus without answers to some key questions," he continues. "Why wasn't an advisory committee used to debate the importance of this unusual (perhaps unprecedented) preclinical finding before FDA made its decision? … If FDA believes the skin finding to be a pharmacological effect of DPP-IV inhibition, why hasn't it alerted prescribers and users of Merck's Januvia, the first drug product in this new class?"